Abbott nabs FDA approval for new CardioMEMS HF System that allows heart readings to be seen at home

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The updates allow U.S. CardioMEMS patients to view their pulmonary artery pressure readings directly on their smartphones. ()

Abbott has been given U.S. clearance for new updates to its CardioMEMS HF System that allow for patient-facing capabilities through its CardioGuide HF App. 

The updates allow U.S. CardioMEMS patients to view their pulmonary artery pressure (PAP) readings directly on their smartphones and are designed to help them take a more active role in their care.

Heart failure can worsen before symptoms become noticeable. The pressure of blood flowing from the heart to the lungs can rise as heart failure worsens, often weeks before patients experience any symptoms. 

The CardioMEMS HF System measures pulmonary artery pressure through an implanted sensor in the pulmonary artery to detect potential heart failure. Clinicians have already used readings from the CardioMEMS HF System to help identify signs of worsening heart failure and guide treatment for more than a decade.

The approved updates are part of a broader effort by the medtech industry to deliver personalized care tools and health monitoring through smartphones and sensing technology. 

Boston Scientific’s HeartLogic remotely measures heart sounds, thoracic impedance, respiratory rate, heart rate and activity to help identify impending heart-failure decompensation to alert physicians of heart failure. 

But while HeartLogic requires ICD/CRT-D device surgical implantation, the CardioMEMS sensor is implanted through a minimally invasive catheter-based procedure and only monitors PAP readings.

"Heart failure can worsen before patients notice shortness of breath, swelling or weight gain. Pulmonary artery pressure readings can help identify changes earlier, giving care teams an opportunity to adjust treatment before symptoms develop," said Andrew J. Sauer, M.D., cardiologist and vice president for research at Saint Luke's Mid America Heart Institute and professor of medicine at the University of Missouri-Kansas City., in a statement. 

"By giving patients access to their pressure trends and personalized guidance from their care team, the CardioGuide HF App can help patients better understand their condition, understand why treatment adjustments are recommended, and take a more active role in managing their heart failure."

New CardioMEMS HF System capabilities also include Dynamic Treatment Plan (DTP), a software feature that allows clinicians to set up personalized medication adjustment plans based on changes in a patient's pulmonary artery pressure. Once in place, DTP can send medication adjustment instructions directly to CardioMEMS patients through the CardioGuide HF App, ensuring patients receive timely feedback and guidance from their care team.

Abbott plans to make the CardioGuide HF App and Dynamic Treatment Plan available later this year.